Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gilead Sciences
Age
18–65
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
All participants:
Be a nonsmoker or consume \< 20 cigarettes per day
Have a calculated body mass index (BMI) from 18 to 36 kg/m\^2, inclusive, at study screening
Have a creatinine clearance (CrCl) ≥ 60 mL/min (using the Cockcroft-Gault method) based on serum creatinine and actual body weight as measured at screening
Have either a normal 12-lead electrocardiogram (ECG) or one with abnormalities that are considered clinically insignificant by the investigator
Screening labs within defined thresholds
Must have diagnosis of chronic (\> 6 months), stable hepatic impairment with no clinically significant changes within 3 months (90 days) prior to study drug administration (Day 1)
Individuals with severe hepatic impairment must have a score on the Child-Pugh-Turcotte scale of 10-15 at screening. If an individual's score changes during the course of the study, the score at screening will be used for classification.
Individuals with moderate hepatic impairment must have a score on the Child-Pugh-Turcotte scale of 7-9 at screening. If an individual's score changes during the course of the study, the score at Screening will be used for classification.
Individuals with mild hepatic impairment must have a score on the Child-Pugh-Turcotte scale of 5-6 at screening. If an individual's score changes during the course of the study, the score at screening will be used for classification.
You may not be if
Pregnant or lactating females
History of meningitis or encephalitis, epilepsy, seizures, migraines, tremors, myoclonic jerks, narcolepsy, obstructive sleep apnea, anxiety, syncope, head injuries or a family history of seizures
Presence or history of cardiovascular disease (including history of myocardial infarction based on ECG and/or clinical history, any history of ventricular tachycardia, congestive heart failure, cardiomyopathy, or left ventricular ejection fraction \< 40%), cardiac conduction abnormalities, a family history of Long QT Syndrome, or unexplained death in an otherwise healthy individual between the ages of 1 and 30 years
Syncope, palpitations, or unexplained dizziness
Implanted defibrillator or pacemaker
Are unable to comply with study requirements or are otherwise believed, by the study investigator, to be inappropriate for study participation for any reason
Active hepatitis B virus (HBV) infection. Individuals who have HBsAg are ineligible
Requires paracentesis \> 1 time per month
Severe (grade 3 or 4) encephalopathy as judged by the investigator
History of gastric or esophageal variceal bleeding within the past 6 months and for which varices have not been adequately treated with medication and/or surgical procedures
Clareo Health | Pharmacokinetics of Eleclazine in Adults With Normal and Impaired Hepatic Function
